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Background and Aims It has been proposed that more use should be made of Bayes factors in hypothesis testing in addiction research. Bayes factors are the ratios of the likelihood of a specified hypothesis (e.g. an intervention effect within a given range) to another hypothesis (e.g. no effect). They are particularly important for differentiating lack of strong evidence for an effect and evidence for lack of an effect. This paper reviewed randomized trials reported in Addiction between January and June 2013 to assess how far Bayes factors might improve the interpretation of the data. Methods Seventy-five effect sizes and their standard errors were extracted from 12 trials. Seventy-three per cent ( n = 55) of these were non-significant (i.e. P > 0.05). For each non-significant finding a Bayes factor was calculated using a population effect derived from previous research. In sensitivity analyses, a further two Bayes factors were calculated assuming clinically meaningful and plausible ranges around this population effect. Results Twenty per cent ( n = 11) of the non-significant Bayes factors were < ⅓ and 3.6% ( n = 2) were > 3. The other 76.4% ( n = 42) of Bayes factors were between ⅓ and 3. Of these, 26 were in the direction of there being an effect (Bayes factor > 1 and < 3); 12 tended to favour the hypothesis of no effect (Bayes factor < 1 and > ⅓); and for four there was no evidence either way (Bayes factor = 1). In sensitivity analyses, 13.3% of Bayes Factors were < ⅓ ( n = 20), 62.7% ( n = 94) were between ⅓ and 3 and 24.0% ( n = 36) were > 3, showing good concordance with the main results. Conclusions Use of Bayes factors when analysing data from randomized trials of interventions in addiction research can provide important information that would lead to more precise conclusions than are obtained typically using currently prevailing methods. [ABSTRACT FROM AUTHOR]

Aims This study examines the preliminary outcomes of an intervention targeting service providers in methadone maintenance therapy ( MMT) clinics in China. The intervention effects on both service providers and clients are reported. Design The MMT CARE intervention pilot was developed and implemented collaboratively with local health educators. After three group intervention sessions, trained providers in intervention clinics delivered two individual motivational interviewing sessions with their clients. Settings Six clinics in Sichuan, China, were randomized to either the MMT CARE intervention condition or a standard care condition. Participants A total of 41 providers and 179 clients were sampled from the six clinics. Measurements At baseline and three-, six-, and nine-month assessments, providers completed self-administrated paper/pencil questionnaires regarding provider-client interaction, MMT knowledge, perceived job-related stigma and clinic support. Clients completed a face-to-face survey about their concurrent drug use and drug avoidance self-efficacy. Mixed-effects regression models with clinic-level random effect were used to assess the intervention effects. Findings Significant intervention effects for providers were found in improved MMT knowledge, provider-client interaction and perceived clinic support. For clients, better improvements in drug avoidance self-efficacy and reduced concurrent drug use were observed for the intervention compared with the standard care group. Conclusions The MMT CARE intervention targeting providers in methadone maintenance clinics can improve providers' treatment knowledge and their interaction with clients. The intervention can also reduce clients' drug-using behavior through motivational interviewing sessions conducted by trained providers. [ABSTRACT FROM AUTHOR]

Background and aims: Alcohol use disorder (AUD) is a chronic disorder with high relapse rates. There are currently few clinical trials of high frequency repetitive transcranial magnetic stimulation (HF‐rTMS) to reduce alcohol use among AUD patients, and results are mixed. The current study tested the effect of 10 add‐on sessions of HF‐rTMS over the right dorsolateral pre‐frontal cortex (DLPFC) on alcohol use and craving. Design: Single‐center, single blind sham‐controlled parallel‐group RCT (n = 80), with 3 and 6 months follow‐up. Setting: Clinical treatment center in Amsterdam, the Netherlands. Participants: Eighty detoxified and abstinent AUD inpatients in clinical treatment (20 females, average age = 44.35 years). Intervention: Ten sessions of active or sham HF‐rTMS (60 10 Hz trains of 5 sec at 110% motor threshold) over the right DLPFC on 10 consecutive work‐days. Measurements The primary outcome measure is the number of abstinent days over 6‐month follow‐up (FU). Secondary outcome measures are craving over 6‐month FU (alcohol urge questionnaire and obsessive‐compulsive drinking scale), time to first relapse over 6‐month FU and grams of alcohol consumed over 6‐month FU. Additional outcome measures: full abstinence over 6‐month FU and treatment success over 12‐month FU. Findings HF‐rTMS did not affect the number of abstinent days over 6 months FU [sham = 124 ± 65.9 days, active = 115 ± 69.8 days, difference: 9 days, 95% confidence interval (CI) = Poisson model: 0.578–3.547]. Moreover, HF‐rTMS did not affect craving (AUQ/OCDS) (sham = 15.38/5.28, active = 17.48/4.75, differences = 2.1/−0.53, 95% CI mixed‐effects model = −9.14 to 2.07/−1.44 to 2.40). Conclusions: There was no clear evidence that high‐frequency repetitive transcranial magnetic stimulation over the right dorsolateral pre‐frontal cortex treatment has a long‐term positive effect on alcohol use or craving as add‐on treatment for alcohol use disorder. High treatment response at 6‐month follow‐up could have limited the possibility to find an effect. [ABSTRACT FROM AUTHOR]

Background and aims: Approach bias modification (ApBM) targeting alcohol approach bias has been previously shown to reduce likelihood of relapse during the first 2 weeks following inpatient withdrawal treatment (IWT). We tested whether ApBM's effects endure for a longer period by analysing alcohol use outcomes 3, 6 and 12 months post‐discharge. Design: A double‐blind, sham‐controlled randomized controlled trial. Setting: Four IWT units in Melbourne, Australia. Participants: Three hundred alcohol IWT patients (173 men, 126 women, 1 non‐binary; mean age 43.5 years) were recruited between 4 June 2017 and 14 July 2019. Follow‐up data collection was completed on 22 September 2020. Intervention and control training: Four ApBM sessions were delivered during IWT. ApBM trained participants (n = 147) to avoid alcohol and approach non‐alcohol beverage cues. Controls (n = 153) responded to the same stimuli, but without approach/avoidance training. Measurements Date of first lapse was recorded for non‐abstinent participants to determine time to first lapse. Time‐line follow‐back interviews assessed past‐month alcohol consumption at each follow‐up, with participants reporting no alcohol consumption classified as abstinent. In analyses of past‐month abstinence, non‐abstinence was assumed in participants lost to follow‐up. Number of past‐month drinking days, standard drinks and heavy drinking days (five or more standard drinks for women or non‐binary; six or more standard drinks for men) were calculated for non‐abstinent participants at each follow‐up. Findings ApBM significantly delayed time to first lapse [ApBM median: 53 days, 95% confidence interval (CI) = 21–61; controls = 12 days, 95% CI = 9–21, P = 0.045]. Past‐month abstinence rates at 3‐, 6‐ and 12‐month follow‐ups were 33/153 (21.6%), 30/153 (19.6%), and 24/153 (15.7%) in controls; and 51/147 (34.7%), 30/147 (20.4%) and 29/147 (19.7%) in the ApBM group, respectively. Past‐month abstinence was significantly more likely in ApBM participants than controls at the 3‐month follow‐up [odds ratio (OR) = 1.93, 95% CI = 1.16–3.23, P = 0.012], but not at 6‐ or 12‐month follow‐ups (6‐month OR = 1.05, 95% CI = 0.60–1.95, P = 0.862; 12‐month OR = 1.32, 95% CI = 0.73–2.40, P = 0.360). No significant group differences were found for indices of alcohol consumption in non‐abstinent participants. Conclusions: Approach bias modification for alcohol delivered during inpatient withdrawal treatment helps to prevent relapse, increasing rates of abstinence from alcohol for at least 3 months post‐discharge. [ABSTRACT FROM AUTHOR]

Aim: To determine whether cytisine was at least as effective as varenicline in supporting smoking abstinence for ≥ 6 months in New Zealand indigenous Māori or whānau (extended‐family) of Māori, given the high smoking prevalence in this population. Design Pragmatic, open‐label, randomized, community‐based non‐inferiority trial. Setting: Bay of Plenty, Tokoroa and Lakes District Health Board regions of New Zealand. Participants: Adult daily smokers who identified as Māori or whānau of Māori, were motivated to quit in the next 2 weeks, were aged ≥ 18 years and were eligible for subsidized varenicline. Recruitment used multi‐media advertising. Interventions: A total of 679 people were randomly assigned (1 : 1) to receive a prescription for 12 weeks of cytisine or varenicline, plus low‐intensity cessation behavioural support from the prescribing doctor and community stop‐smoking services or a research assistant. Day 5 of treatment was the designated quit date. Measurements The primary outcome was carbon monoxide‐verified continuous abstinence at 6 months, analysed as intention‐to‐treat (with multiple imputation for missing data). Secondary outcomes measured at 1, 3, 6 and 12 months post‐quit date included: self‐reported continuous abstinence, 7‐day point prevalence abstinence, cigarettes per day, time to (re)lapse, adverse events, treatment adherence/compliance and acceptability, nicotine withdrawal/urge to smoke and health‐care utilization/health‐related quality of life. Findings Verified continuous abstinence rates at 6 months post‐quit date were 12.1% (41 of 337) for cytisine versus 7.9% (27 of 342) for varenicline [risk difference 4.29%, 95% confidence interval (CI) = –0.22 to 8.79; relative risk 1.55; 95% CI = 0.97–2.46]. Sensitivity analyses confirmed that the findings were robust. Self‐reported adverse events over 6 months occurred significantly more frequently in the varenicline group (cytisine: 313 events in 111 participants; varenicline: 509 events in 138 participants, incidence rate ratio 0.56, 95% CI = 0.49–0.65, P < 0.001) compared with the cytisine group. Common adverse events were headache, nausea and difficulty sleeping. Conclusion: A randomized controlled trial found that cytisine was at least as effective as varenicline at supporting smoking abstinence in New Zealand indigenous Māori or whānau (extended‐family) of Māori, with significantly fewer adverse events. [ABSTRACT FROM AUTHOR]

Background and aims: Evidence for efficacy of brief alcohol interventions (BAIs) is mainly limited to primary care and at‐risk drinkers. The aim was to test the efficacy of a BAI addressing the full spectrum of alcohol use in a general population sample and across alcohol risk groups. Design Two‐parallel‐group randomized controlled trial (allocation ratio 1:1) with post‐baseline assessments at months 3, 6 and 12. Setting: One municipal registry office in Germany responsible for registration, passport and vehicle admission issues. Participants: A total of 1646 proactively recruited 18–64‐year‐old adults with past year alcohol use (56% women, 66% low‐risk drinkers) were randomized to intervention (n = 815) or control (n = 831). Intervention and comparator: The intervention consisted of assessment plus computer‐generated individualized feedback letters at baseline and months 3 and 6. Comparator was assessment only. Measurements Primary outcome was change in the self‐reported number of drinks/week from baseline to 12 months. Changes at 3 and 6 months were secondary outcomes. Moderator was alcohol risk group (low‐risk versus at‐risk drinking) according to the Alcohol Use Disorders Identification Test–Consumption, with scores from 1‐3 (women) and from 1‐4 (men) indicating low‐risk drinking. Findings For the whole sample, significant group differences were observed neither at 12‐month follow‐up [incidence rate ratio (IRR) = 1.01, 95% confidence interval (CI) = 0.87–1.17, Bayes factor (BE) = 0.52] nor at previous assessments (month 3: IRR = 1.01, 95% CI = 0.92–1.12, BE = 0.41; month 6: IRR = 0.93, 95% CI = 0.81–1.07, BE = 1.10). Moderator analyses revealed that low‐risk drinkers were more likely to benefit from BAI only at month 6 than at‐risk drinkers (IRR = 0.77, 95% CI = 0.70–0.86). Conclusions: In a randomized controlled trial, there was no clear evidence for efficacy of a computer‐based brief alcohol intervention in a general population sample, but there was some evidence of medium‐term benefits in the large but understudied group of low‐risk drinkers. [ABSTRACT FROM AUTHOR]

Background and aim: To address the widespread severe problems with opioid use disorder, buprenorphine–naloxone treatment provided by primary care physicians has greatly expanded treatment access; however, treatment is often provided with minimal or no behavioral interventions. Whether or which behavioral interventions are feasible to implement in various settings and improve treatment outcomes has not been established. This study aimed to evaluate two behavioral interventions to improve buprenorphine–naloxone treatment. Design A 2 × 2 factorial, repeated‐measures, open‐label, randomized clinical trial. Settings General medical practice offices in Muar, Malaysia. Participants: Opioid‐dependent individuals (n = 234). Interventions: Participants were randomly assigned to one of four treatment conditions and received study interventions for 24 weeks: (1) physician management with or without behavioral counseling and (2) physician management with or without abstinence‐contingent buprenorphine–naloxone (ACB) take‐home doses. Measurements The primary outcomes were proportions of opioid‐negative urine tests and HIV risk behaviors [assessed by audio computer‐assisted AIDS risk inventory (ACASI‐ARI)]. Findings The rates of opioid‐negative urine tests over 24 weeks of treatment were significantly higher with [68.2%, 95% confidence interval (CI) = 65–71] than without behavioral counseling (59.2%, 95% CI = 56–62, P < 0.001) and with (71.0%, 95% CI = 68–74) than without ACB (56.4%, 95% CI = 53–59, P < 0.001); interaction effects between and among behavioral interventions and time were not statistically significant. Scores on ACASI‐ARI decreased significantly from baseline across all treatment groups (P < 0.001) and did not differ significantly with or without behavioral counseling (P = 0.099) or with or without ACB (P = 0.339). Conclusions: Providing opioid‐dependent patients in Muar, Malaysia with buprenorphine–naloxone and physician management plus behavioral counseling or abstinence‐contingent buprenorphine–naloxone (ACB) resulted in greater reductions of opioid use compared with providing buprenorphine–naloxone and physician management without behavioral counseling or ACB. [ABSTRACT FROM AUTHOR]

Aims: To assess the effectiveness of training stop smoking services providers in Malaysia to deliver support for smoking cessation based on the UK National Centre for Smoking Cessation and Training (NCSCT) standard treatment programme compared with usual care. Design Two‐arm cluster‐randomized controlled effectiveness trial across 19 sites with follow‐up at 4‐week, 3‐month, and 6‐month. Setting: Stop smoking services operating in public hospitals in Malaysia. Participants: Five hundred and two smokers [mean ± standard deviation (SD), age 45.6 (13.4) years; 97.4% male] attending stop smoking services in hospital settings in Malaysia: 330 in 10 hospitals in the intervention condition and 172 in nine hospitals in the control condition. Intervention and comparator: The intervention consisted of training stop‐smoking practitioners to deliver support and follow‐up according to the NCSCT Standard Treatment Programme. The comparator was usual care (brief support and follow‐up). Measurements: The primary outcome was continuous tobacco smoking abstinence up to 6 months in smokers who received smoking cessation treatment, verified by expired‐air carbon monoxide (CO) concentration. Secondary outcomes were continuous CO‐verified tobacco smoking abstinence up to 4 weeks and 3 months. Results: Follow‐up rates at 4 weeks, 3 months and 6 months were 80.0, 70.6 and 53.3%, respectively, in the intervention group and 48.8, 30.8 and 23.3%, respectively, in the control group. At 6‐month follow‐up, 93 participants in the intervention group and 19 participants in the control group were abstinent from smoking, representing 28.2 versus 11.0% in an intention‐to‐treat (ITT) analysis assuming that participants with missing data had resumed smoking, and 52.8 versus 47.5% in a follow‐up‐only (FUO) analysis. Unadjusted odds ratios (accounting for clustering) were 5.04, (95% confidence interval (CI) = 1.22–20.77, P = 0.025) and 1.70, (95% CI = 0.25–11.53, P = 0.589) in the ITT and FUO analyses, respectively. Abstinence rates at 4 week and 3 month follow‐ups were significantly higher in the intervention versus control group in the ITT but not the FUO analysis. Conclusions: On an intention‐to‐treat analysis with missing‐equals‐smoking imputation, training Malaysian stop smoking service providers in the UK National Centre for Smoking Cessation and Training standard treatment programme appeared to increase 6 month continuous abstinence rates in smokers seeking help with stopping compared with usual care. However, the effect may have been due to increasing follow‐up rates. [ABSTRACT FROM AUTHOR]

Background and aims: The UK low‐risk drinking guidelines (LRDG) recommend not regularly drinking more than 14 units of alcohol per week. We tested the effect of different pictorial representations of alcohol content, some with a health warning, on knowledge of the LRDG and understanding of how many drinks it equates to. Design Parallel randomized controlled trial. Setting: On‐line, 25 January–1 February 2019. Participants: Participants (n = 7516) were English, aged over 18 years and drink alcohol. Interventions: The control group saw existing industry‐standard labels; six intervention groups saw designs based on: food labels (serving or serving and container), pictographs (servings or containers), pie charts (servings) or risk gradients. A total of 500 participants (~70 per condition) saw a health warning under the design. Measurements Primary outcomes: (i) knowledge: proportion who answered that the LRDG is 14 units; and (ii) understanding: how many servings/containers of beverages one can drink before reaching 14 units (10 questions, average distance from correct answer). Findings In the control group, 21.5% knew the LRDG; proportions were higher in intervention groups (all P < 0.001). The three best‐performing designs had the LRDG in a separate statement, beneath the pictograph container: 51.1% [adjusted odds ratio (aOR) = 3.74, 95% confidence interval (CI) = 3.08–4.54], pictograph serving 48.8% (aOR = 4.11, 95% CI = 3.39–4.99) and pie‐chart serving, 47.5% (aOR = 3.57, 95% CI = 2.93–4.34). Participants underestimated how many servings they could drink: control mean = −4.64, standard deviation (SD) = 3.43; intervention groups were more accurate (all P < 0.001), best performing was pictograph serving (mean = −0.93, SD = 3.43). Participants overestimated how many containers they could drink: control mean = 0.09, SD = 1.02; intervention groups overestimated even more (all P < 0.007), worst‐performing was food label serving (mean = 1.10, SD = 1.27). Participants judged the alcohol content of beers more accurately than wine or spirits. The inclusion of a health warning had no statistically significant effect on any measure. Conclusions: Labels with enhanced pictorial representations of alcohol content improved knowledge and understanding of the UK's low‐risk drinking guidelines compared with industry‐standard labels; health warnings did not improve knowledge or understanding of low‐risk drinking guidelines. Designs that improved knowledge most had the low‐risk drinking guidelines in a separate statement located beneath the graphics. [ABSTRACT FROM AUTHOR]

Background and aims: Culturally relevant and feasible interventions are needed to address limited professional resources in sub‐Saharan Africa for behaviorally treating the dual epidemics of HIV and alcohol use disorder. This study tested the efficacy of a cognitive–behavioral therapy (CBT) intervention to reduce alcohol use among HIV‐infected outpatients in Eldoret, Kenya. Design Randomized clinical trial. Setting: A large HIV outpatient clinic in Eldoret, Kenya, affiliated with the Academic Model Providing Access to Healthcare collaboration. Participants: A total of 614 HIV‐infected outpatients [312 CBT; 302 healthy life‐styles (HL); 48.5% male; mean age: 38.9 years; mean education 7.7 years] who reported a minimum of hazardous or binge drinking. Intervention and comparator: A culturally adapted six‐session gender‐stratified group CBT intervention compared with HL education, each delivered by paraprofessionals over six weekly 90‐minute sessions with a 9‐month follow‐up. Measurements Primary outcome measures were percentage of drinking days (PDD) and mean drinks per drinking day (DDD) computed from retrospective daily number of drinks data obtained by use of the time‐line follow‐back from baseline to 9 months post‐intervention. Exploratory analyses examined unprotected sex and number of partners. Findings Median attendance was six sessions across condition. Retention at 9 months post‐intervention was high and similar by condition: CBT 86% and HL 83%. PDD and DDD marginal means were significantly lower in CBT than HL at all three study phases. Maintenance period, PDD – CBT = 3.64 (0.696), HL = 5.72 (0.71), mean difference 2.08, 95% confidence interval (CI) = 0.13 – 4.04; DDD – CBT = 0.66 (0.96), HL = 0.98 (0.098), mean difference = 0.31, 95% CI = 0.05 – 0.58. Risky sex decreased over time in both conditions, with a temporary effect for CBT at the 1‐month follow‐up. Conclusions: A cognitive–behavioral therapy intervention was more efficacious than healthy lifestyles education in reducing alcohol use among HIV‐infected Kenyan outpatient drinkers. [ABSTRACT FROM AUTHOR]

Aims: To test the efficacy of a brief intervention to reduce alcohol or drug use and to promote use of addiction services among patients seeking mental health treatment. Design and setting: A multi‐centre, longitudinal, two‐group randomized controlled trial with randomization within each of two mental health treatment systems located in Ventura County and Los Angeles County in California, USA. Participants: A total of 718 patients (49.2% female) aged 18 and older with a mental health diagnosis and either a heavy drinking day or any use of cannabis or stimulants in the past 90 days. Intervention and comparator: A motivation‐based brief intervention with personalized feedback (screening, brief intervention and referral to treatment (SBIRT) condition) (n = 354) or a health education session (control condition) (n = 364). Measurements Primary outcomes included frequency of heavy drinking days, days of cannabis use and days of stimulant use at the primary end‐point 3 months post‐baseline. Secondary outcomes included frequency and abstinence from substance use out to a 12‐month follow‐up and the use of addiction treatment services. Findings Participants in the SBIRT condition had fewer heavy drinking days [odds ratio (OR) = 0.53; 95% credible interval (CrI) = 0.48–0.6] and fewer days of stimulant use (OR = 0.58; 95% CrI = 0.50–0.66) at the 3‐month follow‐up compared with participants in the health education condition. Participants in the SBIRT condition did not comparatively reduce days of cannabis use at the 3‐month follow‐up (OR = 0.93; 95% CrI = 0.85–1.01). Secondary outcomes indicated sustained effects of SBIRT on reducing the frequency of heavy drinking days and days of stimulant use. No effects were observed on abstinence rates or use of addiction treatment services. Conclusions: Screening and brief intervention for unhealthy alcohol and drug use in mental health treatment settings were effective at reducing the frequency of heavy drinking and stimulant use. [ABSTRACT FROM AUTHOR]

Aims: To examine variability and effectiveness of interventions provided to comparator (control) groups in smoking cessation trials. Methods: Systematic review with meta‐analysis of randomized controlled trials (RCTs) of behavioral interventions for smoking cessation, with or without stop‐smoking medication. We searched the Cochrane Tobacco Addiction Group Specialized Register for RCTs with objective outcomes measured at ≥ 6 months. Study authors were contacted to obtain comprehensive descriptions of their comparator interventions. Meta‐regression analyses examined the relationships of smoking cessation rates with stop‐smoking medication and behavior change techniques. Results: One hundred and four of 142 eligible comparator groups (n = 23 706) had complete data and were included in analyses. There was considerable variability in the number of behavior change techniques delivered [mean = 15.97, standard deviation (SD) = 13.54, range = 0–45] and the provision of smoking cessation medication (43% of groups received medication) throughout and within categories of comparator groups (e.g. usual care, brief advice). Higher smoking cessation rates were predicted by provision of medication [B = 0.334, 95% confidence interval (CI) = 0.030–0.638, P = 0.031] and number of behavior change techniques included (B = 0.020, 95% CI = 0.008–0.032, P < 0.001). Modelled cessation rates in comparator groups that received the most intensive support were 15 percentage points higher than those that received the least (23 versus 8%). Conclusions: Interventions delivered to comparator groups in smoking cessation randomized controlled trials vary considerably in content, and cessation rates are strongly predicted by stop‐smoking medication and number of behavior change techniques delivered. [ABSTRACT FROM AUTHOR]

Aim: Aims were to test the effectiveness of an organizational change intervention integrating smoking cessation treatment into usual alcohol and other drug (AOD) treatment, compared with usual care, on (1) 7‐day point prevalence abstinence (PPA) at 8 weeks follow‐up; (2) prolonged abstinence; (3) cigarettes smoked per day; (4) number of quit attempts; and (5) offer and use of nicotine replacement therapy (NRT). All outcomes were assessed at 8 weeks and 6.5 months follow‐up. Design Cluster‐randomized controlled trial, with AOD service as unit of randomization, conducted January 2015–March 2016. Setting: Thirty‐two eligible services (provided face‐to‐face client sessions to ≥ 50 clients/year) in Australia were randomized to control (usual care; n = 15) or intervention (n = 17) groups by an independent blinded biostatistician. Participants: Eligible participants (≥ 16 years, current smoker) completed surveys at the service at baseline (n = 896) and telephone follow‐up surveys (conducted by blinded assessors) at 8 weeks (n = 471; 53%) and 6.5 months (n = 427; 48%). Intervention: Intervention services received an intervention to establish routine screening, assessment and delivery of smoking cessation care. Measurements Primary outcome was biochemically verified 7‐day PPA at 8‐week follow‐up. Secondary outcomes included verified and self‐reported prolonged abstinence, self‐reported 7‐day PPA, cigarettes/day, quit attempts and offer and use of NRT. Intention‐to‐treat analyses were performed, assuming missing participants were not abstinent. Findings At 8 weeks, the findings in verified 7‐day PPA between groups [2.6 versus 1.8%, odds ratio (OR) = 1.72, 95% confidence interval (CI) = 0.5–5.7, P = 0.373] were inconclusive as to whether a difference was present. Significantly lower mean cigarettes/day were reported in the intervention group compared to the usual care group at 8 weeks [incidence rate ratio (IRR) = 0.88, 95% CI = 0.8–0.95, P = 0.001] but were similar at 6.5 months (IRR = 0.96, 95% CI = 0.9–1.02, P = 0.240) follow‐up. At both follow‐ups the intervention group reported higher rates of NRT use. Conclusions: Integrating smoking cessation treatment into addiction services did not significantly improve short‐term abstinence from smoking. [ABSTRACT FROM AUTHOR]

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Aim: To test the effectiveness of a motivational interviewing (MI) intervention using the mobile phone among adults with alcohol use problems. Design A randomized clinical trial of mobile MI and standard in‐person MI with 1‐ and 6‐month follow‐up, including a 1‐month waitlist control followed by mobile MI. Setting: A primary health center in rural Kenya. Participants: Three hundred adults screening positive for alcohol use problems were randomized and received immediate mobile MI (n = 89), in‐person MI (n = 65) or delayed mobile MI (n = 76) for waiting‐list controls 1 month after no treatment, with 70 unable to be reached for intervention. Intervention and comparator: One MI session was provided either immediately by mobile phone, in‐person at the health center or delayed by 1 month and then provided by mobile phone. Measurements Alcohol use problems were repeatedly assessed using the Alcohol Use Disorder Identification Test (AUDIT) and the shorter AUDIT‐C. The primary outcome was difference in alcohol score 1 month after no intervention for waiting‐list control versus 1 month after MI for mobile MI. The secondary outcomes were difference in alcohol score for in‐person MI versus mobile MI one and 6 months after MI. Findings For our primary outcome, average AUDIT‐C scores were nearly three points higher (difference = 2.88, 95% confidence interval = 2.11, 3.66) for waiting‐list controls after 1 month of no intervention versus mobile MI 1 month after intervention. Results for secondary outcomes supported the null hypothesis of no difference between in‐person and mobile MI at 1 month (Bayes factor = 0.22), but were inconclusive at 6 months (Bayes factor = 0.41). Conclusion: Mobile phone‐based motivational interviewing may be an effective treatment for alcohol use problems among adults visiting primary care in Kenya. Providing mobile motivational interviewing may help clinicians in rural areas to reach patients needing treatment for alcohol use problems. [ABSTRACT FROM AUTHOR]

Aim To examine the efficacy and safety of (1) midazolam-droperidol versus droperidol and (2) midazolam-droperidol versus olanzapine for methamphetamine-related acute agitation. Design and setting A multi-centre, randomized, double-blind, controlled, clinical trial was conducted in two Australian emergency departments, between October 2014 and September 2015. Participants Three hundred and sixty-one patients, aged 18-65 years, requiring intravenous medication sedation for acute agitation, were enrolled into this study. We report the results of a subgroup of 92 methamphetamine-affected patients. Intervention and comparator Patients were assigned randomly to receive either an intravenous bolus of midazolam 5 mg-droperidol 5 mg combined, droperidol 10 mg or olanzapine 10 mg. Two additional doses were administered, if required: midazolam 5 mg, droperidol 5 mg or olanzapine 5 mg, respectively. Measurements The primary outcome was the proportion of patients sedated adequately at 10 minutes. Odds ratios with 95% confidence intervals (ORs, 95% CI) were estimated. Findings The baseline characteristics of patients in the three groups were similar. At 10 minutes, significantly more patients in the midazolam-droperidol group [29 of 34 (85.3%)] were sedated adequately compared with the droperidol group [14 of 30 (46.7%), OR = 6.63, 95% CI = 2.02-21.78] or with the olanzapine group [14 of 28 (50.0%), OR 5.80, 95% CI = 1.74-19.33]. The number of patients who experienced an adverse event (AE) in the midazolam-droperidol, droperidol and olanzapine groups was seven of 34, two of 30 and six of 28, respectively. The most common AE was oxygen desaturation. Conclusion A midazolam-droperidol combination appears to provide more rapid sedation of patients with methamphetamine-related acute agitation than droperidol or olanzapine alone. [ABSTRACT FROM AUTHOR]

Aims To test whether, in comparison to usual care, brief motivational or reduction interventions increase quit attempts (QA) or abstinence among smokers who are not ready to quit. Design A parallel-group randomized controlled trial of brief motivational ( n = 185), reduction ( n = 186) or usual care ( n = 189) telephone interventions delivered over the course of 4 weeks. Outcomes were assessed at 6- and 12-month follow-ups. No medication was provided. Setting United States. Participants A total of 560 adult smokers of ≥ 10 cigarettes per day who were not ready to quit in the next 30 days. Measurements The primary outcomes were whether participants made a QA that lasted ≥ 24 hours and whether they made a QA of any length between baseline and 6 months. Secondary outcomes included 7-day point-prevalence abstinence at 6 and 12 months. The 12-month follow-up was added after the study began. Findings A priori-defined comparisons were between motivational versus usual care and reduction versus usual care conditions. The probability of making a QA that lasted ≥ 24 hours was not significantly different between the motivational (38%) or the reduction (31%) conditions and the usual care (34%) condition [motivational versus usual care odds ratio (OR) = 1.19, 95% confidence interval (CI) = 0.78-1.82; reduction versus usual care OR = 0.89, 95% CI = 0.57-1.36]. Bayes factors ranged from 0.13 to 0.18. Findings regarding a QA of any length were similar. At 6 months, the motivational condition had marginally more abstinence than usual care (11 versus 5%, OR = 2.17, 95% CI = 0.99-4.77), but the reduction condition was not significantly different from usual care (8 versus 5%, OR = 1.57, 95% CI = 0.69-3.59). At 12 months, the motivational condition had significantly more abstinence than usual care (10 versus 4%, OR = 2.80, 95% CI = 1.14-6.88) and the reduction condition had marginally more abstinence than usual care (9 versus 4%, OR = 2.45, 95% CI = 0.98-6.09). Conclusions Among adult smokers who are not ready to quit, both logistic regression and Bayesian analysis indicate that neither motivational nor reduction-based telephone interventions increased the odds of making a quit attempt in comparison to usual care at 6 months. The motivational intervention appeared to increase abstinence at 6 months and did increase abstinence at 12 months. The reduction intervention did not increase abstinence at 6 months but appeared to increase abstinence at 12 months. [ABSTRACT FROM AUTHOR]

Aims To determine the effectiveness and safety of varenicline in treating tobacco dependence in patients with severe mental illness. Design A systematic reviewand meta-analysis of randomised controlled trials that compared varenicline with a placebo or an alternative intervention for smoking cessation or reduction. Setting Both in- and out-patient settings in any country. Participants Adult patients aged 18 years and over with any type of severe mental illness. The systematic review included eight studies comprising 398 participants. Measures Primary outcome measures were (1) smoking cessation, (2) smoking reduction measured by changes in the number of cigarettes smoked per day and (3) number of psychiatric adverse events, which were collected at the end of treatment. Findings The random-effect pooled estimates from the five studies that reported smoking-related outcomes found that varenicline is statistically superior to placebo in smoking cessation [risk ratios 4.33; 95% confidence interval (CI)=1.96-9.56], and smoking reduction was higher in varenicline groups (mean reduced daily cigarettes was 6.39; 95% CI=2.22-10.56). There is no significant difference regarding neuropsychiatric and other adverse events. Conclusions Varenicline appears to be significantly more effective than placebo in assisting with smoking cessation and reduction in people with severe mental illness. There appears to be no clear evidence that varenicline was associated with an increased risk of neuropsychiatric or other adverse events compared with placebo. [ABSTRACT FROM AUTHOR]

Aims To examine the safety and effectiveness of buprenorphine + naloxone sublingual tablets (BUP, as Suboxone®) provided after administration of extended-release injectable naltrexone (XR-NTX, as Vivitrol®) to reduce cocaine use in participants who met DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. Methods This multi-centered, double-blind, placebo-controlled study, conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network, randomly assigned 302 participants at sites in California, Oregon, Washington, Colorado, Texas, Georgia, Ohio, New York and Washington DC, USA to one of three conditions provided with XR-NTX: 4 mg/day BUP (BUP4, n = 100), 16 mg/day BUP (BUP16, n = 100, or no buprenorphine (placebo; PLB, n = 102). Participants received pharmacotherapy for 8 weeks, with three clinic visits per week. Cognitive behavioral therapy was provided weekly. Follow-up assessments occurred at 1 and 3 months post-intervention. The planned primary outcome was urine drug screen (UDS)-corrected, self-reported cocaine use during the last 4 weeks of treatment. Planned secondary analyses assessed cocaine use by UDS, medication adherence, retention and adverse events. Results No group differences were found between groups for the primary outcome (BUP4 versus PLB, P = 0.262; BUP16 versus PLB, P = 0.185). Longitudinal analysis of UDS data during the evaluation period using generalized linear mixed equations found a statistically significant difference between BUP16 and PLB [ P = 0.022, odds ratio (OR) = 1.71] but not for BUP4 ( P = 0.105, OR = 1.05). No secondary outcome differences across groups were found for adherence, retention or adverse events. Conclusions Buprenorphine + naloxone, used in combination with naltrexone, may be associated with reductions in cocaine use among people who meet DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. [ABSTRACT FROM AUTHOR]

Aims To assess the efficacy of topiramate in treating cocaine use disorder (i.e. retention, efficacy, safety and craving reduction) through a systematic review and meta-analysis. Methods We searched six scientific databases from inception to 23 December 2014 with no date limits. Data were reviewed, extracted and analysed systematically. Studies were included if they were peer-reviewed randomized control trials with participants meeting diagnostic criteria for cocaine dependence or cocaine use disorder, with the treatment arm involving topiramate with or without psychosocial intervention, and the control arm involving no intervention or psychosocial intervention with or without placebo. A random-effects meta-analytical model was computed. Results Five studies met inclusion criteria ( n = 518). Topiramate was compared with placebo (four studies) and no medication (one study). In a meta-analysis, we observed no significant differences between topiramate and placebo in improving treatment retention risk ratio (RR) = 0.85; 95% confidence interval (CI) = 0.60-1.22, P = 0.38. However, compared with a placebo, use of topiramate was associated with increased continuous abstinence in two of five studies (RR = 2.43; 95% CI = 1.31-4.53, P = 0.005). No differences were observed in frequency of adverse effects reported between topiramate and placebo (RR = 1.06; 95% CI = 0.91-1.23, P = 0.48). Topiramate was associated significantly ( P < 0.05) with a reduction in craving in only one of five studies. Conclusions Evidence does not currently support the use of topiramate to improve treatment retention for cocaine use disorder, although it may extend cocaine abstinence with a similar risk of adverse events compared with placebo. [ABSTRACT FROM AUTHOR]

Aims To determine the efficacy of acamprosate and naltrexone in the treatment of those who are alcohol-dependent in reducing lapse/relapse to alcohol consumption and treatment discontinuation, and to examine whether a proportion of the variance in study outcome can be explained by the country in which the trials have taken place. Method A systematic review and meta-analysis of randomized controlled trials published before September 2013 was conducted. The primary outcome measures were the efficacy of acamprosate or naltrexone in reducing lapse/relapse compared to placebo in the treatment of alcohol dependence and treatment discontinuation. Twenty-two randomized controlled trials (RCTs) of the efficacy of acamprosate met inclusion criteria for the meta-analysis, with a total of 2649 participants in the acamprosate group and 2587 in the placebo group. Twenty-seven RCTs of the efficacy of naltrexone met inclusion criteria for the meta-analysis, with a total of 2253 participants in the naltrexone group and 1946 in the placebo group. A random-effects model using a Mantel-Haenszel method was applied to conduct the meta-analysis. Variance in study outcomes was explored using subgroup analysis of Europe versus the rest of the world (ROW). Results The risk of returning to any drinking at 6 months was significantly lower for acamprosate [risk ratio (RR) = 0.83, 95% confidence interval (CI) = 0.78-0.89]. There was little difference in the risk of participants discontinuing treatment for any reason (RR = 0.91, 95% CI = 0.83-1.00) or due to adverse events (RR = 1.30, 95% CI = 0.96-1.75) for the acamprosate compared to placebo groups. The risk of individuals returning to any drinking at approximately 3 months was reduced significantly for the naltrexone group (RR = 0.92, 95% CI = 0.86-1.00), as was the risk of individuals relapsing to heavy drinking at 3 months (RR = 0.85, 95% CI = 0.78-0.93). There was no significant difference between naltrexone and placebo for the risk of individuals discontinuing treatment for any reason (RR = 0.94, 95% CI = 0.84-1.05). There was a significantly greater risk of participants in the naltrexone group discontinuing treatment due to adverse events compared to placebo (RR = 1.72, 95% CI = 1.10-2.70). Subgroup analysis by country (Europe versus ROW) revealed no difference in risk between acamprosate and placebo for the outcomes returning to any drinking at 6 months and discontinuing treatment due to adverse events. For the outcome discontinuation of treatment for any reason, there was a significant difference in RR between Europe and the ROW (χ2 = 11.65, P <0.001) for acamprosate. Acamprosate was associated with a reduction in risk of discontinuing treatment for Europe (RR = 0.86, 95% CI = 0.79-0.95), but an increase in risk of discontinuing treatment for ROW (RR = 1.23, 95% CI = 1.03-1.48). Conclusions Both acamprosate and naltrexone appear to reduce the risk of individuals returning to drinking alcohol in those who are alcohol-dependent. The country in which a randomized control trial (RCT) for the efficacy of acamprosate and naltrexone is completed does not appear to explain the variance in trial outcomes for returning to drinking alcohol or discontinuing drinking due to adverse effects. However, the country in which the RCT of acamprosate are completed may be important for explaining the variance between studies for the outcome 'discontinuing treatment for any reason'. [ABSTRACT FROM AUTHOR]

Aims The Randomized Injectable Opioid Treatment Trial ( RIOTT) compared supervised injectable heroin ( SIH) and supervised injectable methadone ( SIM) with optimized oral methadone ( OOM) ( ISRCTN0133807). Heroin addicts (previously unresponsive to treatment) made significant reductions in street heroin use at 6 months when treated with SIH. We now examine secondary outcomes. Design Multi-site randomized controlled trial ( RCT) comparing SIH versus OOM and SIM versus OOM. Setting Three supervised injectable opiate clinics in England. Participants Chronic refractory heroin addicts continuing to inject street heroin virtually daily despite oral substitution treatment ( n = 127), randomized to either SIH( n = 43), SIM( n = 42) or OOM( n = 42). All received high levels of medical and psychosocial support. Measurements Secondary outcomes: wider drug use, crime, health and social functioning at 6 months. Findings At 6 months, no significant differences were found between treatment groups in wider drug use (crack/cocaine, benzodiazepines, alcohol), physical and mental health ( SF-36) or social functioning. Within each treatment group, significant reductions were observed in crime [ SIH = odds ratio ( OR) 0.05; P < 0.001; SIM = OR 0.11; P = 0.002; OOM = OR 0.11; P = 0.003] and money spent per week on illicit drugs ( SIH = mean change £-289.43; P < 0.001; SIM = mean change £-183.41; P < 0.001; OOM = mean change £-162.80; P < 0.001), with SIH significantly more likely to have reduced money spent on illicit drugs versus OOM (mean difference £-92.04; P < 0.001). Significant improvements were seen in physical health for SIH and SIM ( SIH = mean change 3.97; P = 0.008; SIM = mean change 4.73; P = 0.002) and mental health for OOM (mean change 6.04; P = 0.013). Conclusions Supervised injectable heroin treatment and supervised injectable methadone treatment showed no clearly identified benefit over optimized oral methadone in terms of wider drug use, crime, physical and mental health within a 6-month period, despite reducing street heroin use to a greater extent. However, all interventions were associated with improvements in these outcomes. [ABSTRACT FROM AUTHOR]

Aims To assess the relations of menthol cigarette use with measures of cessation success in a large comparative effectiveness trial ( CET). Design Participants were randomized to one of six medication treatment conditions in a randomized double-blind, placebo-controlled clinical trial. All participants received six individual counseling sessions. Setting Community-based smokers in two communities in Wisconsin, USA. Participants A total of 1504 adult smokers who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. The analysis sample comprised 1439 participants: 814 white non-menthol smokers, 439 white menthol smokers and 186 African American ( AA) menthol smokers. There were too few AA non-menthol smokers ( n = 16) to be included in the analyses. Interventions Nicotine lozenge, nicotine patch, bupropion sustained release, nicotine patch + nicotine lozenge, bupropion + nicotine lozenge and placebo. Measurements Biochemically confirmed 7-day point-prevalence abstinence assessed at 4, 8 and 26 weeks post-quit. Findings In longitudinal abstinence analyses (generalized estimating equations) controlling for cessation treatment, menthol smoking was associated with reduced likelihood of smoking cessation success relative to non-menthol smoking [model-based estimates of abstinence = 31 versus 38%, respectively; odds ratio ( OR) = 0.71, 95% confidence interval ( CI) = 0.59, 0.86]. In addition, among menthol smokers, AA women were at especially high risk of cessation failure relative to white women (estimated abstinence = 17 versus 35%, respectively; OR = 2.63, 95% CI = 1.75, 3.96; estimated abstinence rates for AA males and white males were both 30%, OR = 1.06, 95% CI = 0.60, 1.66). Conclusion In the United States, smoking menthol cigarettes appears to be associated with reduced cessation success compared with non-menthol smoking, especially in African American females. [ABSTRACT FROM AUTHOR]

Aims Investigators of the COMBINE ( Combining Medications and Behavioral Interventions for Alcoholism) study examined whether combining medications with a behavioral intervention would improve outcomes over monotherapies. Unexpectedly, the combination did not offer any advantage over either treatment alone. This study aimed to explain the lack of incremental benefit offered by the combination over either monotherapy by assessing the role of cravings as a treatment mediator and moderator. Design Secondary mediation and moderation analyses of COMBINE study data. Setting Eleven United States academic sites. Participants A total of 863 patients randomized to one of four treatment groups: naltrexone (100 mg/day; n = 209), the combined behavioral intervention ( CBI, n = 236), naltrexone and CBI combined ( n = 213) and placebo naltrexone ( n = 205). Measurements Percentage of days abstinent ( PDA) measured between 13 and 16 weeks post-baseline. Cravings, the potential mediator/moderator, were measured at baseline, weeks 4 and 12 using the Obsessive- Compulsive Drinking Scale. Findings Compared with placebo, naltrexone, CBI and the combination all increased PDA by an additional 6-10 percentage points for those with high cravings ( P < 0.05 for all three treatment groups). None had significant effects on PDA for those with low cravings. The effects of all three treatments were mediated at least partially by cravings; craving reduction explained 48-53% of treatment effects ( P < 0.05 for all three treatment groups). Furthermore, naltrexone appeared to reduce cravings at 4 weeks, while CBI did not reduce cravings until 12 weeks. Conclusions The Combining Medications and Behavioral Interventions for Alcoholism ( COMBINE) naltrexone + CBI combination may not be more beneficial than either monotherapy because craving reduction is a common mechanism of both. [ABSTRACT FROM AUTHOR]

Aims To assess the effects of adding motivational interviewing ( MI) counseling to nicotine patch for smoking cessation among homeless smokers. Design Two-group randomized controlled trial with 26-week follow-up. Participants and setting A total of 430 homeless smokers from emergency shelters and transitional housing units in Minneapolis/ St Paul, Minnesota, USA. Intervention and measurements All participants received 8-week treatment of 21-mg nicotine patch. In addition, participants in the intervention group received six individual sessions of MI counseling which aimed to increase adherence to nicotine patches and to motivate cessation. Participants in the standard care control group received one session of brief advice to quit smoking. Primary outcome was 7-day abstinence from cigarette smoking at 26 weeks, as validated by exhaled carbon monoxide and salivary cotinine. Findings Using intention-to-treat analysis, verified 7-day abstinence rate at week 26 for the intervention group was non-significantly higher than for the control group (9.3% versus 5.6%, P = 0.15). Among participants who did not quit smoking, reduction in number of cigarettes from baseline to week 26 was equally high in both study groups (−13.7 ± 11.9 for MI versus −13.5 ± 16.2 for standard care). Conclusions Adding motivational interviewing counseling to nicotine patch did not increase smoking rate significantly at 26-week follow-up for homeless smokers. [ABSTRACT FROM AUTHOR]

Aims To test aripiprazole for efficacy in decreasing use in methamphetamine-dependent adults, compared to placebo. Design Participants were randomized to receive 12 weeks of aripiprazole or placebo, with a 3-month follow-up and a platform of weekly 30-minute substance abuse counseling. Setting The trial was conducted from January 2009 to March 2012 at the San Francisco Department of Public Health. Participants Ninety actively using, methamphetamine-dependent, sexually active adults were recruited from community venues. Measurements The primary outcome was regression estimated reductions in weekly methamphetamine-positive urines. Secondary outcomes were study medication adherence [by self-report and medication event monitoring systems ( MEMS)], sexual risk behavior and abstinence from methamphetamine. Findings Participant mean age was 38.7 years, 87.8% were male, 50.0% white, 18.9% African American, and 16.7% Latino. Eighty-three per cent of follow-up visits and final visits were completed. By intent-to-treat, participants assigned to aripiprazole had similar reductions in methamphetamine-positive urines as participants assigned to placebo [risk ratio ( RR) 0.88, 95% confidence interval ( CI): 0.66-1.19, P = 0.41]. Urine positivity declined from 73% (33 of 45 participants) to 45% (18 of 40) in the placebo arm and from 77% (34 of 44) to 44% (20 of 35) in the aripiprazole arm. Adherence by MEMS and self-report was 42 and 74%, respectively, with no significant difference between arms ( MEMS P = 0.31; self-report P = 0.17). Most sexual risk behaviors declined similarly among participants in both arms (all P > 0.05). There were no serious adverse events related to study drug, although participants randomized to aripiprazole reported more akathisia, fatigue and drowsiness ( P < 0.05). Conclusion Compared with placebo, aripiprazole did not reduce methamphetamine use significantly among actively using, dependent adults. [ABSTRACT FROM AUTHOR]

Aims To test the population impact of offering automated smoking cessation interventions via the internet and/or by mobile phone. Design Pragmatic randomized controlled trial with five conditions: offer of (i) minimal intervention control; (ii) QuitCoach personalized tailored internet-delivered advice program; (iii) on Q, an interactive automated text-messaging program; (iv) an integration of both QuitCoach and on Q; and (v) a choice of either alone or the combined program. Setting Australia, via a mix of internet and telephone contacts. Participants A total of 3530 smokers or recent quitters recruited from those interested in quitting, and seeking self-help resources ( n = 1335) or cold-contacted from internet panels ( n = 2195). Measurements The primary outcome was self-report of 6 months sustained abstinence at 7 months post-recruitment. Findings Only 42.5% of those offered one of the interventions took it up to a minimal level. The intervention groups combined had a non-significantly higher 6-month sustained abstinence rate than the control [odds ratio ( OR) = 1.48; 95% confidence interval (CI): 0.98-2.24] (missing cases treated as smokers), with no differences between the interventions. Among those who used an intervention, there was a significant overall increase in abstinence ( OR = 1.95; CI: 1.04-3.67), but not clearly so when analysing only cases with reported outcomes. Success rates were greater among those recruited after seeking information compared to those cold-contacted. Conclusions Smokers interested in quitting who were assigned randomly to an offer of either the QuitCoach internet-based support program and/or the interactive automated text-messaging program had non-significantly greater odds of quitting for at least 6 months than those randomized to an offer of a simple information website. [ABSTRACT FROM AUTHOR]

Aims Like many indigenous peoples, New Zealand Māori bear a heavy burden of alcohol-related harm relative to their non-indigenous compatriots, and disparities are greatest among young adults. We tested the effectiveness of web-based alcohol screening and brief intervention (e- SBI) for reducing hazardous drinking among Māori university students. Design Parallel, double-blind, multi-site, randomized controlled trial. Setting Seven of New Zealand's eight universities. Participants In April 2010, we sent e-mail invitations to all 6697 17-24-year-old Māori students to complete a brief web questionnaire including the Alcohol Use Disorders Identification Test ( AUDIT)- C, a screening tool for hazardous and harmful drinking. Those screening positive were computer randomized to: <10 minutes of web-based alcohol assessment and personalized feedback (intervention) or screening alone (control). Measurements We conducted a fully automated 5-month follow-up assessment with observers and participants blinded to study hypotheses, design and intervention delivery. Pre-determined primary outcomes were: (i) frequency of drinking, (ii) amount consumed per typical drinking occasion, (iii) overall volume of alcohol consumed and (iv) academic problems. Findings Of the participants, 1789 were hazardous or harmful drinkers ( AUDIT- C ≥ 4) and were randomized: 850 to control, 939 to intervention. Follow-up assessments were completed by 682 controls (80%) and 733 intervention group members (78%). Relative to controls, participants receiving intervention drank less often [ RR = 0.89; 95% confidence interval (CI): 0.82-0.97], less per drinking occasion ( RR = 0.92; 95% CI: 0.84-1.00), less overall ( RR = 0.78; 95% CI: 0.69-0.89) and had fewer academic problems ( RR = 0.81; 95% CI: 0.69-0.95). Conclusions Web-based screening and brief intervention reduced hazardous and harmful drinking among non-help-seeking Māori students in a large-scale pragmatic trial. The study has wider implications for behavioural intervention in the important but neglected area of indigenous health. [ABSTRACT FROM AUTHOR]

Aims To evaluate the efficacy of a telephone-based intervention consisting of four sessions of motivational interviewing ( MI) and cognitive behavioural therapy ( CBT) designed to assist individuals to reduce their cannabis use and related problems. Design Random allocation to intervention or delayed treatment control with 4- and 12-week follow-up assessments. Setting Counsellors from the Cannabis Information and Helpline ( CIH), an Australian reactive telephone service, delivered the intervention to callers seeking treatment. Participants A total of 160 participants were recruited by the CIH, with 110 participants completing the final follow-up assessment (69% retention). Measurements Cannabis use, dependence and related problems and other substance use were assessed at baseline and follow-up. Findings Intervention participants reported greater reductions in dependence symptoms [ P < 0.001, d = 0.9 (0.5-1.3)] and related problems [ P < 0.001, d = 0.5 (0.1-0.9)] compared with control participants at both follow-up assessments. Compared with control, intervention participants reported greater confidence to reduce cannabis use at 4 weeks [ P = 0.002, d = 0.5 (0.1-0.9)], and in turn reported a greater percentage of abstinent days at 12 weeks [ P = 0.019, d = 0.6 (0.2-1.0)]. Conclusions A brief course of motivational interviewing plus cognitive behavioural therapy delivered by telephone can help to reduce cannabis dependence and promote abstinence in the short term. [ABSTRACT FROM AUTHOR]

Aims To determine whether web-based tailored cessation advice, based on social cognitive theory and the perspectives on change model, was more effective in aiding a quit attempt than broadly similar web-based advice that was not tailored. Design Participants were allocated randomly to one of two groups, to receive either a cessation advice report and progress report that were tailored to individual-level characteristics or a cessation advice report that presented standardized (non-tailored) content. Tailoring was based on smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations. Setting Participant enrolment and baseline assessments were conducted remotely online via the study website, with the advice reports presented by the same website. Participants Participants ( n = 1758) were visitors to the QUIT website who were based in the United Kingdom, aged 18 years or over and who smoked cigarettes or hand-rolled tobacco. Measurements Follow-up assessments were made at 6 months by telephone interview. The primary outcome measure was self-reported 3 months prolonged abstinence, and secondary outcomes were 1 month prolonged abstinence, 7-day and 24-hour point prevalence abstinence. Findings The intervention group did not differ from the control group on the primary outcome (9.1% versus 9.3%; odds ratio = 1.02 95% confidence interval 0.73-1.42) or on any of the secondary outcomes. Intervention participants gave more positive evaluations of the materials than control participants. Conclusions A web-based intervention that tailored content according to smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations, was not more effective than web-based materials presenting broadly similar non-tailored information. [ABSTRACT FROM AUTHOR]

Aims To examine the relationship of anxiety and depression symptoms with treatment outcomes (treatment discontinuation, rates of ongoing use of illicit drugs and likelihood of preterm delivery) in opioid-dependent pregnant women and describe their use of psychotropic medications. Design and setting Secondary data analysis from a randomized clinical trial of treatment for opioid dependence during pregnancy. Participants A total of 175 opioid-dependent pregnant women, of whom 131 completed treatment. Measurements Symptoms of anxiety and depression were captured with the 15-item Mini International Neuropsychiatric Interview ( MINI) screen. Use of illicit drugs was measured by urine drug screening. Preterm delivery was defined as delivery prior to 37 weeks' gestation. Self-reported use of concomitant psychotropic medication at any point during the study was recorded. Findings Women reporting only anxiety symptoms at study entry were more likely to discontinue treatment [adjusted odds ratio ( OR) = 4.56, 95% confidence interval ( CI): 1.91-13.26, P = 0.012], while those reporting only depression symptoms were less likely to discontinue treatment (adjusted OR = 0.14, 95% CI: 0.20-0.88, P = 0.036) compared to women who reported neither depression nor anxiety symptoms. No statistically significant between-group differences were observed for ongoing illicit drug use or preterm delivery. A majority (61.4%) of women reported use of concomitant psychotropic medication at some point during study participation. Conclusions Opioid agonist-treated pregnant patients with co-occurring symptoms of anxiety require additional clinical resources to prevent premature discontinuation. [ABSTRACT FROM AUTHOR]

Aim To determine pre- and post-dosing effects of prenatal methadone compared to buprenorphine on fetal wellbeing. Design A secondary analysis of data derived from the Maternal Opioid Treatment: Human Experimental Research ( MOTHER) study, a double-blind, double-dummy, randomized clinical trial. Setting Six United States sites and one European site that provided comprehensive opioid-dependence treatment to pregnant women. Participants Eighty-one of the 131 opioid-dependent pregnant women completing the MOTHER clinical trial, assessed between 31 and 33 weeks of gestation. Measurements Two fetal assessments were conducted, once before and once after study medication dosing. Measures included mean fetal heart rate ( FHR), number of FHR accelerations, FHR reactivity in the fetal non-stress test ( NST) and biophysical profile ( BPP) score. Findings Significant group differences were found for number of FHR accelerations, non-reactive NST and BPP scores (all Ps < 0.05). There were no significant group differences before time of dosing. Significant decreases (all Ps < 0.05) occurred from pre- to post-dose assessment for mean FHR, FHR accelerations, reactive NST and fetal movement. The decrease in accelerations and reactive NST were significant only for fetuses in the methadone group, and this resulted in a significantly lower likelihood of a reactive NST compared to fetuses in the buprenorphine group. Conclusion Buprenorphine compared with methadone appears to result in less suppression of mean fetal heart rate, fetal heart rate reactivity and the biophysical profile score after medication dosing and these findings provide support for the relative safety of buprenorphine when fetal indices are considered as part of the complete risk-benefit ratio. [ABSTRACT FROM AUTHOR]

Aim To examine hepatic enzyme test results throughout the course of pregnancy in women maintained on methadone or buprenorphine. Design Participants were randomized to either methadone or buprenorphine maintenance. Blood chemistry tests, including liver transaminases and hepatitis C virus ( HCV) status, were determined every 4 weeks and once postpartum. As part of a planned secondary analysis, generalized mixed linear models were conducted with aspartate aminotransferase ( AST), alanine aminotransferase ( ALT) and gamma-glutamyl transferase ( GGT) as the dependent variables. Setting Six US sites and one European site that provided comprehensive treatment to pregnant opioid-dependent women. Participants A total of 175 opioid-dependent pregnant women enrolled in the Maternal Opioid Treatment: Human Experimental Research ( MOTHER) study. Findings ALT, AST and GGT levels decreased for all subjects across pregnancy trimesters, rising slightly postpartum. HCV-positive subjects exhibited higher transaminases at all time-points compared to HCV-negative subjects, regardless of medication (all Ps < 0.05) condition. Both HCV-positive and negative buprenorphine-maintained participants exhibited lower GGT levels than those who were methadone-maintained ( P < 0.05). Conclusions Neither methadone nor buprenorphine appear to have adverse hepatic effects in the treatment of pregnant opioid-dependent women. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims The purpose of the current study was to evaluate feasibility and efficacy of two promising approaches to indicated prevention of disordered gambling in a college population. Design Randomized clinical trial with assignment to a personalized feedback intervention (PFI), cognitive-behavioral intervention (CBI) or assessment-only control (AOC). PFI was delivered individually in a single session and included feedback regarding gambling behavior, norms, consequences and risk-reduction tips, delivered in a motivational interviewing style. CBI was delivered in small groups over four to six sessions and included functional analysis and brief cognitive correction, as well as identification of and alternatives for responding to gambling triggers. Setting College campus. Participants At-risk or probable pathological gamblers ( n = 147; 65.3% male; group assignment: PFI, n = 52; CBI, n = 44; AOC, n = 51). Measurements Self-reported gambling quantity, frequency, consequences, psychopathology, normative perceptions and beliefs. Findings Relative to control, results at 6-month follow-up indicated reductions in both interventions for gambling consequences (PFI d = 0.48; CBI d = 0.39) and DSM-IV criteria (PFI d = 0.60; CBI d = 0.48), reductions in frequency for PFI ( d = 0.48). CBI was associated with reduced illusions of control, whereas PFI was associated with reduced perceptions of gambling frequency norms. Reductions in perceived gambling frequency norms mediated effects of PFI on gambling frequency. Conclusions A single-session personalized feedback intervention and a multi-session cognitive-behavioral intervention may be helpful in reducing disordered gambling in US college students. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims To determine whether collaborative behavioral management (CBM) reduces substance use, crime and re-arrest among drug-involved parolees. Design Step'n Out was a randomized behavioral trial of CBM versus standard parole (SP) during 2004-08. CBM adapted evidence-based role induction, behavioral contracting and contingent reinforcement to provide parole officer/treatment counselor dyads with positive tools in addition to sanctions to manage parolees' behavior over 12 weeks. Setting Six parole offices in five states in the USA. Participants Parolee volunteers with a mandate for addiction treatment and a minimum of 3 months of parole ( n = 476). Follow-up was 94% at 3 months and 86% at 9 months. Measurements Drug use and crime in a given month from calendar interviews 3 and 9 months after parole initiation, and re-arrests from criminal justice administrative data. Findings The CBM group had fewer months in which they used their primary drug [adjusted risk ratio (ARR) 0.20, 95% confidence interval (CI): 0.05, 0.78, P = 0.02] and alcohol (ARR 0.38, 95% CI: 0.22, 0.66, P = 0.006) over follow-up. CBM had its greatest effects among parolees who reported marijuana or another 'non-hard' drug as their primary drug; parolees who preferred stimulants or opiates did not benefit. No differences were seen in total crime, re-arrests or parole revocations. Conclusions Collaborative behavioral management may reduce substance use among primary marijuana or other 'non-hard' drug-using parolees without increasing revocations. Because the majority of drug violation arrests in the United States are for marijuana, these findings have important implications for the management of a substantial proportion of the US community correctional population. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims This study aimed to determine the relative effectiveness of 12 months of interim methadone (IM; supervised methadone with emergency counseling only for the first 4 months of treatment), standard methadone treatment (SM; with routine counseling) and restored methadone treatment (RM: routine counseling with smaller case-loads). Design A randomized controlled trial was conducted comparing IM, SM and RM treatment. IM lasted for 4 months, after which participants were transferred to SM. Setting The study was conducted in two methadone treatment programs in Baltimore, MD, USA. Participants The study included 230 adult methadone patients newly admitted through waiting-lists. Measurements We administered the Addiction Severity Index and a supplemental questionnaire at baseline, 4 and 12 months post- baseline. Measurements included retention in treatment, self-reported days of heroin and cocaine use, criminal behavior and arrests and urine tests for heroin and cocaine metabolites. Findings At 12 months, on an intent-to-treat basis, there were no significant differences in retention in treatment among the IM, SM and RM groups (60.6%, 54.8% and 37.0%, respectively). Positive urine tests for the three groups declined significantly from baseline ( Ps < 0.001 and 0.003, for heroin and cocaine metabolites, respectively) but there were no significant group x time interactions for these measures. At least one arrest was reported by 30.6% of the sample during the year, but there were no significant between-group effects. Conclusions Limited availability of drug counseling services should not be a barrier to providing supervised methadone to adults dependent on heroin-at least for the first 4 months of treatment. [ABSTRACT FROM AUTHOR]